61
Participants
Start Date
December 1, 2017
Primary Completion Date
January 13, 2023
Study Completion Date
December 31, 2036
ODM-201
ODM-201 is a novel, oral, potent nonsteroidal AR inhibitor. ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) b.i.d. to a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food. Treatment should be initiated within 28 days from randomization.
ADT
"ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.~This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician."
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme, Brussels
Cliniques Universitaires Saint-Luc, Brussels
CHU Dinant Godinne - UCL Namur, Yvoir
Universitair Ziekenhuis Gent, Ghent
Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Ospedale Molinette, Torino
CHU de Dijon - Centre Georges-Francois-Leclerc, Dijon
Hospital Universitario Ramon y Cajal, Madrid
Hospital Universitario Virgen De La Victoria, Málaga
Hospital Universitario de Salamanca, Salamanca
Fundacion Instituto Valenciano De Oncologia, Valencia
Gustave Roussy, Villejuif
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol, Badalona
Collaborators (1)
Bayer
INDUSTRY
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK